GRAIL has announced that new data for its investigational multi-cancer early detection blood test will be presented at the American Association for Cancer Research (AACR) Virtual Annual Meeting. These new data evaluate the performance of GRAIL’s test in symptomatic participants with suspicion of cancer.
Today, the majority of deadly cancers do not have screening tests that are recommended by guidelines, and as a result, most cancers aren’t detected util they have progressed to late stages when chances of survival are much lower. There is a great unmet need for early detection in the diagnostic assessment of patients who are being evaluated for cancer. GRAIL’s multi-cancer early detection test can detect more than 50 cancers, with a false-positive rate of less than 1 percent, through a single blood draw. The test can also detect the tissue of origin—where the cancer is located in the body—with high accuracy, and could be particularly useful in creating more effective diagnostic workups for symptomatic patients being evaluated for cancer.
“We continue to make significant progress in the validation of our multi-cancer early detection blood test, and wanted to assess its potential to drive efficiencies in the diagnostic workup of patients who are showing symptoms,” said GRAIL Chief Scientific Officer, Head of R&D, and Co-founder Alex Aravanis, MD, Ph.D. “These findings show that when our multi-cancer test detected a cancer signal, it also identified where in the body that cancer was located with high accuracy. This is critical information for health care providers, and demonstrates the feasibility of our test to potentially accelerate diagnosis in individuals with high suspicion of cancer by helping direct the diagnostic workup.”
The new data GRAIL will present represent a pre-specified subgroup from GRAIL’s Circulating Cell-free Genome Atlas (CCGA) study, which included more than 15,000 participants with or without a diagnosis of cancer. In the subgroup analysis that will be reported at AACR, participants being evaluated for suspicion of cancer were classified as clinically confirmed cancer or clinically confirmed non-cancer. In the confirmed non-cancer group, all training and validation samples were correctly predicted as non-cancer, or 100% specificity.
In the validation set, detection across all stages in the confirmed cancer was 46.7 percent. When renal cancers, which were overrepresented and subject to poor detection at early stages due to low tumor cfDNA fraction, were not included, detection across stages was 59.3 percent. In stages II and above, accuracy was 85.5 percent. And for cancers where a signal was detected, the tissue or origin was predicted in 93.9 percent of samples in training and 100 percent of those in validation.
Read the original press release here.